Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis - PMSIT

Dept of Neurology0 个研究点开始时间: 2009年4月24日最近更新: 2017年7月24日

试验速览

暂无简介。

•A subject will be eligible for inclusion in this study if all of the following criteria apply:
•Between the age of 18 and 65 years of age
•Progressive MS since at least three years
•Some kind of documented progression of neurological symptoms during the previ-ous two years.
•EDSS 4,0 - 7.0 (inclusive) (basically spared arm functions)
•Conventional therapy not indicated, contraindicated or failed
•Judged as compliant with the protocol
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•A subject will not be eligible for inclusion in this study if any of the following criteria ap-plies:
•Eligible for any of the conventional MS therapies
•Bleeding diathesis or medication contraindicating neurosurgical procedures or lumbar puncture
•Cognitive defect making informed consent unreliable
•Any medidal condition contraindicating minor surgical procedures, as judged by anaesthesiologist
•Severe uncontrolled heart disease
•Pregnant or lactating women
•Patients having contraindication for or otherwise not compliant with MRI investigations
•Documented vulnerability to infections
•Simultaneous treatment with other immunosuppressive drugs
•Documented allergy or intolerance to Rituximab
•Severe psychiatric condition

发起方